UK’s MHRA Grants Marketing Authorisation for Pfizer’s CIBINQO® (abrocitinib) for Adults and Adolescents With Moderate to Severe Atopic Dermatitis
-Abrocitinib is a once-daily oral JAK1 inhibitor indicated in
-This is the first marketing authorization globally for abrocitinib-
“We welcome the MHRA’s authorization of abrocitinib to treat people with moderate to severe atopic dermatitis. This is an important development for people in
Last year, abrocitinib received a Promising Innovative Medicine (PIM) designation from the MHRA. In January of this year, abrocitinib was granted a positive scientific opinion for an Early Access to Medicines Scheme (EAMS) from the MHRA for people with severe atopic dermatitis requiring treatment with systemic therapy and who have had inadequate response or have lost response to licensed systemic therapies, or who are ineligible or intolerant of licensed systemic therapies. This enabled healthcare professionals to prescribe the treatment prior to marketing authorization, based on clinical factors for patients with a clear unmet need.
Regulatory applications for abrocitinib have been submitted to countries around the world for review, including
About Atopic Dermatitis
AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects.i,ii Lesions of AD are characterized by erythema (skin turning red or purple depending on normal skin color), itching, induration (hardening)/papulation (formulation of papules), and oozing/crusting.ii,iii
AD is one of the most common, chronic, relapsing childhood dermatoses, affecting up to 10% of adults and up to 20% of children worldwide.iii,iv AD is the most common chronic inflammatory skin disease in the
About CIBINQO® (abrocitinib)
CIBINQO (abrocitinib) is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of AD, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).vii
A total of 3,128 patients were treated with CIBINQO in clinical studies in atopic dermatitis. There were 994 patients with at least 48 weeks of exposure. Five placebo‑controlled studies were integrated (703 patients on 100mg once daily, 684 patients on 200mg once daily and 438 patients on placebo) to evaluate the safety of CIBINQO in comparison to placebo for up to 16 weeks.
The most commonly reported adverse reactions occurring in ≥ 2% of patients treated with CIBINQO 200mg in placebo-controlled studies are: nausea (15.1%), headache (7.9%), acne (4.8%), herpes simplex (4.2%), blood creatine phosphokinase increased (3.8%), vomiting (3.5%), dizziness (3.4%) and abdominal pain upper (2.2%). The most frequent serious adverse reactions are infections (0.3%).
For further safety information including warnings, precautions and adverse reactions, please refer to the Summary of Product Characteristics.
The information contained in this release is as of
This release contains forward-looking information about a product candidate, abrocitinib, including an approval by the MHRA and their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any other jurisdictions for any potential indication for abrocitinib; whether and when the applications for abrocitinib pending with the
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended
i Hanifin JM, Reed ML. A population-based survey of eczema in
ii Bieber T. Atopic dermatitis. Dermatology. 2012;1(3):203-217.
iii Oszukowska M, Michalak I, Gutfreund K, et al. Role of primary and secondary prevention in atopic dermatitis. Postep Derm Alergol. 2015:32(6):409-420.
iv Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab. 2015;66(suppl 1):8-16.
v Weidinger S, Beck LA, Bieber T, Kabashima K, Irvine AD. Atopic dermatitis. Nature Reviews Disease Primers. 2018;4(1):1.
vii Silverberg J I, et al. Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis. JAMA Dermatology. 2020;156(8): 863-873